The following data is part of a premarket notification filed by Cochlear Americas with the FDA for Cochlear Osia 2 System, Cochlear Osia Osi200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear Mri Kit.
| Device ID | K220922 |
| 510k Number | K220922 |
| Device Name: | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
| Contact | Samata Veluvolu |
| Correspondent | Samata Veluvolu Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09321502065924 | K220922 | 000 |